Unilateral dual-target (STN/GPi) D… for Parkinson's (NCT06169852)
Optimize brain stimulation for movement
- Trial ID
- NCT06169852
- Official Title
- Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
- Goal
- Optimize brain stimulation for movement
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Alabama at Birmingham
- Study Type
- INTERVENTIONAL
- Enrollment
- 36 participants
- Conditions
- Parkinson Disease
- Interventions
- Unilateral dual-target (STN/GPi) DBS
Summary For Families
The team wants to understand how deep brain stimulation changes local brain activity and to develop implantable tools that record the brain's immediate responses to stimulation so those signals can guide where electrodes go and how the stimulator is programmed. Participants will, in a blinded and randomized order, try one-sided stimulation of the subthalamic nucleus, one-sided stimulation of the globus pallidus interna, and stimulation of both targets together, with motor and non-motor outcomes checked every four months while researchers analyze the stimulation-evoked signals. Adults 18 to 89 with at least four years of Parkinson's who are planning awake deep brain stimulation surgery because medications leave disabling motor problems, who show clear benefit from Parkinson's medication like levodopa, and who meet routine cognitive, mood, safety, and insurance requirements can enroll.
Locations
- University of Alabama at Birmingham, Birmingham, Alabama, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Unilateral dual-target (STN/GPi) DBS. The team wants to understand how deep brain stimulation changes local brain activity and to develop implantable tools that record the brain's immediate responses to stimulation so those signals can guide where electrodes go and how the stimulator is programmed. Participants will, in a blinded and randomized order, try one-sided stimulation of the subthalamic nucleus, one-sided stimulation of the globus pallidus interna, and stimulation of both targets together, with motor and non-motor outcomes checked every four months while researchers analyze the stimulation-evoked signals. Adults 18 to 89 with at least four years of Parkinson's who are planning awake deep brain stimulation surgery because medications leave disabling motor problems, who show clear benefit from Parkinson's medication like levodopa, and who meet routine cognitive, mood, safety, and insurance requirements can enroll.
- Who can participate?
- Participants must be between 18 Years and 89 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 4 years and 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- How many visits does this trial involve?
- Assessments are done at 4-month intervals after surgery compared to a pre-operative baseline, and the blinded visits are followed by an unblinded open-label encounter at 16 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Surgical procedure (invasive). Confirm the full schedule with the study coordinator.